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一项关于盖胃平治疗反流性食管炎的多中心随机临床试验。

A multicentric, randomized clinical trial of Gaviscon in reflux esophagitis.

作者信息

McHardy G

出版信息

South Med J. 1978 Jan;71 Suppl 1:16-21. doi: 10.1097/00007611-197801001-00004.

Abstract

Gaviscon tablets and the standard antacid proved equally effective in reducing the number of heartburn attacks. Chi-square tests revealed no significant difference between the two treatment groups at the end of weeks 1, 2, 3, or 4. Heartburn score was arrived at by multiplying heartburn incidence by heartburn severity. This heartburn score also indicated no significant difference between the two treatment groups at the end of the four weeks. Tabulation of the mean number of tablets consumed by patients in the two groups was made. There was no significant difference between the two groups in tablet consumption, indicating equal demand as well as equal compliance in the two groups. Esophagoscopy done before and after 28 days of treatment showed that Gaviscon and the standard antacid tablets were equally effective in each group. There was significant, and equal, decrease in the severity in the specific signs of esophagitis, friability, erosion, and ulceration in both treatment groups, as well as in such nonspecific signs as hyperemia, edema, and exudate. The validity and clinical acceptance of an alginic acid-containing agent, Gaviscon, which through a foaming action delivers a minimal dose of antacid directly at the site of acid irritation of the esophageal mucosa, has been confirmed in a multicentric, well-controlled randomized clinical trial.

摘要

胃仙-U片和标准抗酸剂在减少烧心发作次数方面同样有效。卡方检验显示,在第1、2、3或4周结束时,两个治疗组之间没有显著差异。烧心评分是通过将烧心发生率乘以烧心严重程度得出的。四周结束时,两个治疗组之间的烧心评分也没有显著差异。对两组患者服用的平均药片数进行了列表统计。两组在药片服用量上没有显著差异,表明两组的需求和依从性相同。治疗28天前后进行的食管镜检查表明,胃仙-U片和标准抗酸剂在每组中同样有效。两个治疗组中食管炎、脆弱性、糜烂和溃疡等特定体征以及充血、水肿和渗出液等非特定体征的严重程度均有显著且相同程度的降低。一种含海藻酸的药物胃仙-U,通过发泡作用将最小剂量的抗酸剂直接送达食管黏膜酸刺激部位,其有效性和临床可接受性已在一项多中心、严格对照的随机临床试验中得到证实。

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